The use of electronics in pharmaceutical devices has become prevalent, especially in the management of assets, particularly those applications associated with inventory management. For example, the use of RFID tags permits the monitoring of the production line and the movement of assets or components through the supply chain. Additionally, these electronics allow more functionality to be embedded in the devices. Such functions as integrity testing, calibration and diagnostics, can now be performed in situ because of the use of these embedded electronics.
To further illustrate one such use of embedded electronics, a manufacturing entity may affix RFID tags to components as they enter the production facility. These components are then inserted into the production flow, forming sub-assemblies in combination with other components, and finally resulting in a finished product. The use of RFID tags allows the personnel within the manufacturing entity to track the movement of the specific component throughout the manufacturing process. It also allows the entity to be able to identify the specific components that comprise any particular assembly or finished product.
In addition, the use of RFID tags has also been advocated within the drug and pharmaceutical industries. In February 2004, the United States Federal and Drug Administration issued a report advocating the use of RFID tags to label and monitor drugs. This is an attempt to provide pedigree and to limit the infiltration of counterfeit prescription drugs into the market and to consumers.
Since their introduction, RFID tags have been used in many applications, such as to identify and provide information for process control in filter products. U.S. Patent RE 39,361, reissued to Den Dekker in 2006, discloses the use of “electronic labels” in conjunction with filtering apparatus and replaceable filter assemblies. Specifically, the patent discloses a filter having an electronic label that has a read/write memory and an associated filtering apparatus that has readout means responsive to the label. The electronic label is adapted to count and store the actual operating hours of the replaceable filter. The filtering apparatus is adapted to allow use or refusal of the filter, based on this real-time number. The patent also discloses that the electronic label can be used to store identification information about the replaceable filter.
U.S. Pat. No. 7,259,675, issued to Baker et al, in 2007, discloses a process equipment tracking system. This system includes the use of RFID tags in conjunction with process equipment. The RFID tag is described as capable of storing “at least one trackable event”. These trackable events are enumerated as cleaning dates, and batch process dates. The publication also discloses an RFID reader that is connectable to a PC or an internet, where a process equipment database exists. This database contains multiple trackable events and can supply information useful in determining “a service life of the process equipment based on the accumulated data”. The application includes the use of this type of system with a variety of process equipment, such as valves, pumps, filters, and ultraviolet lamps.
RFID tags are but one use of embedded electronics as used in pharmaceutical devices. U.S. Pat. No. 7,048,775 issued to Jornitz et al in 2006, discloses a device and method for monitoring the integrity of filtering installations. This publication describes the use of filters containing an onboard memory chip and communications device, in conjunction with a filter housing. The filter housing acts as a monitoring and integrity tester. That application also discloses a set of steps to be used to insure the integrity of the filtering elements used in multi-round housings. These steps include querying the memory element to verify the type of filter that is being used, its limit data, and its production release data.
Other patent applications have also disclosed the use of embedded sensors to aid in diagnostics or in situ integrity tests.
Despite the improvements that have occurred through the use of embedded electronics in pharmaceutical devices, there are additional areas that have not been satisfactorily addressed. For example, to date, embedded electronics and RFID tags cannot be employed in environments that require or utilize radiation. This is due to the fact that most electronic devices, and particularly memory storage devices, cannot withstand radiation. When subjected to radiation, specifically gamma and beta radiation, the contents of these memory elements are corrupted, thereby rendering them useless in this environment. Additionally, certain other electronic components, such as integrated circuits, fail when subjected to radiation. The most common failure mode is a condition commonly referred to as “latchup”. However, there are a number of applications, such as, but not limited to, the drug and pharmaceutical industries, where radiation of the system is a requirement. Furthermore, many electronic components cannot withstand temperature extremes, such as temperatures above 125° C. or below −55° C. These extreme temperatures are used in the pharmaceutical industry to sterilize materials, and to store finished product. Therefore, it would be extremely beneficial to these industries and others, to have embedded electronics that could withstand radiation and/or extreme temperature ranges without data loss or corruption.